Hospitals or Practices Participating in a Clinical Trial
The test mission of the American College of Cardiology (ACC) is to transform cardiovascular care and improve heart health with clinical research as a key component to informing care delivery. Occasionally, hospitals or practices have an opportunity to participate in a clinical trial where study patients will overlap with an NCDR registry population. In these instances, it is possible that a research protocol includes care delivery outside of usual standards or routine clinical practice, and will impact registry reporting. NCDR does not currently have a mechanism to identify study patients for purposes of their exclusion from registry reporting.
ACC is supportive of hospitals and practices participating in clinical trials. The primary objective of the NCDR is to provide measurement reporting to support improvement in care delivery so the impact of patients enrolled in a single, time-limited study to the local site as well as to the national benchmarking will typically be minimal. ACC recognizes that for certain sites participating in specific registry programs, trial participation may have an impact beyond the NCDR’s primary objective to include reporting to stakeholders such as for private payers, state or federal government agencies, or coalitions. ACC encourages hospitals or practices considering involvement in clinical trials that may influence their registry reports to contact these stakeholders directly, ideally prior to a decision to participate in the study to discuss the implications of trial participation.